← FDA DRUG APPROVALS

FDA NDA · NDA208712

VONJO

Sponsor: SOBI

APPLICATION
NDA208712
TYPE
NDA
ORIGINAL APPROVAL
2022-02-28
LATEST ACTION
2026-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

VONJO · ReferencePrescription
PACRITINIB CITRATE EQ 100MG BASE · CAPSULE · ORAL

Approval history

2026-07-20Labeling · Supplement 9 · standard — Letter ↗AP
2026-03-18Labeling · Supplement 7 · standard — Letter ↗AP
2025-10-01Labeling · Supplement 4 · standard — Letter ↗AP
2025-08-22Labeling · Supplement 6 · standard — Label ↗AP
2024-11-12Labeling · Supplement 3 · standard — Letter ↗AP
2023-08-15Labeling · Supplement 1 · standard — Letter ↗AP
2022-02-28Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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